Lose-It: Using the Energy Gap to Prevent Weight Regain

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT00429650
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 175
• Location: 1
• Arms: 3
• Duration (Months): 78.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The major challenge in obesity treatment is not producing weight loss but in preventing that weight from being regained. There are many different methods to lose weight, but there are no recommendations for how you can best achieve long-term weight loss maintenance. Despite the method used to reduce one's body weight, very few of these individuals are able to keep their weight off permanently. This project aims to identify how much activity is necessary to prevent weight regain after weight loss.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: increased exercise; Behavioral: diet; Behavioral: Exercise and Diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 175 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Using the Energy Gap to Prevent Weight Regain
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Increased amount of exercise to maintain weight loss.	Behavioral: increased exercise; Use prescribed number of minutes of exercise 5-6 days per week to maintain weight loss.
Experimental: 2 Combination of Exercise and Diet to maintain weight loss	Behavioral: Exercise and Diet; Use a combination of exercise and diet to maintain weight loss.
Active Comparator: 3 Use diet alone to maintain weight loss.	Behavioral: diet; Use a prescribed diet to maintain weight loss

Outcome Measures

Primary Outcome Measures

1. Change in Weight [18 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. All ethnic groups and both genders

2. Age: Lower age limit: 19 years; Upper age limit: 45 years

3. Body-mass Index: Lower BMI limit: 30 kg/m2; Upper BMI limit: 40 kg/m2 and weight stable within +/- 5 pounds in the last 6 months, and currently at maximum non pregnant body weight (+/- 5%)

4. A negative treadmill stress test or subsequent follow up cardiac testing for cardiac ischemia.

Exclusion Criteria:

1. History of cardiovascular disease, including coronary artery disease, congestive heart failure, & unstable angina, or uncontrolled hypertension ( > 140/90 mm Hg)

2. Currently smoking or stopped smoking in the last 12 months

3. Medications affecting weight, energy intake, or energy expenditure in the last 6 months

4. Use of oral steroids within the last 12 months

5. History of stroke or seizures, thyroid disease, type 1 or 2 diabetes, Cushings syndrome, cerebrovascular, renal disease, hepatic disease, arrhythmias

6. Cancer requiring treatment in the past 5 years, with the exception of skin cancers other than melanoma

7. Infectious diseases: Self-reported HIV positivity or Active tuberculosis

8. Weight loss or weight gain of > 5% in past 6 months for any reason except post-partum weight loss

9. Likely to move away in next 1.5 years

10. Inability to adhere to the program such as inability to increase walking

11. Currently pregnant, lactating or less than 6 months post-partum

12. Major psychiatric disorder: Exclusions related to medications -Antipsychotic agents (these include, but are not limited to: Haldol, Loxitane, Mellaril, Navane, Prolixin, Stelazine, Thorazine, and Trilafon)

13. Current depression by history or Beck Depression Inventory (BDI)

14. Currently being treated for psychological condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Human Nutrition	Denver	Colorado	United States	80262

Sponsors and Collaborators

• University of Colorado, Denver
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Holly R. Wyatt, MD, University of Colorado at Denver Health Sciences Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00429650
• Other Study ID Numbers: 06-0369; R01DK071692
• First Posted: Feb 1, 2007
• Last Update Posted: Jun 28, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by University of Colorado, Denver: Weight maintenance; Weight loss

Study Results

No Results Posted as of Jun 28, 2019